MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER¿ PLASTIC BLOOD COLLECTION TUBES WITH K2EDTA

Catalog Number	368661
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 6187595, medical device expiration date: 12/31/2017, device manufacture date: 07/05/2016; medical device lot #: 6124925, medical device expiration date: 10/31/2017, device manufacture date: 5/3/2016.Results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for clotting with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
Event or Problem Description
It was reported that the bd vacutainer¿ plastic blood collection tubes with k2edta, lavender conventional stopper, 6.0 ml draw, 13x100 mm was clotting.No injury or medical intervention.

• Brand Name: BD VACUTAINER¿ PLASTIC BLOOD COLLECTION TUBES WITH K2EDTA
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7087273
• Report Number: 1917413-2017-00512
• Device Sequence Number: 916795
• Product Code: JKA
• UDI-Device Identifier: 00382903686612
• UDI-Public: 00382903686612
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K981013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 368661
• Device Lot Number: 6187595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other